Trulicity Approved for Use in Combination with Basal Insulin

The approval is based on trial results which included a total of 300 patients with a mean baseline A1C of 8.4%

The labeling for Trulicity (dulaglutide; Eli Lilly) has been updated to include use in combination with basal insulin for adults with type 2 diabetes, following approval from the Food and Drug Administration (FDA).

Trulicity is a once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist injectable used to improve glycemic control in adults with type 2 diabetes. This approval makes it the first GLP-1 receptor agonist with a label that allows its use in combination with mealtime or basal insulin.

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The update was approved by the FDA following a review of results from the AWARD-9 clinical trial, a Phase 3b, placebo-controlled, 28-week study that evaluated the efficacy and safety of once-weekly Trulicity 1.5mg as an add on to titrated insulin glargine compared to placebo as an add-on to titrated insulin glargine. The trial included a total of 300 patients with a mean baseline A1C of 8.4%.

Results showed that Trulicity significantly reduced A1C as an add-on to insulin glargine (1.4%) after 28 weeks compared to placebo plus insulin glargine (0.7%). The most commonly reported adverse events for people taking Trulicity were gastrointestinal-related and were consistent with prior Trulicity studies, including nausea (12%) and diarrhea (11.3%).